Cranberry Juice for Treatment of Urinary Tract Infections

Urinary Tract Infections Clinical Trial

Official title:

Cranberry Juice and Urinary Tract Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00093054
• Other study ID #: R01AT002086
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 30, 2004
• Last updated: April 14, 2015
• Start date: November 2004
• Est. completion date: December 2009

Study information

• Verified date: April 2015
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether daily consumption of cranberry juice lessens the symptoms and prevents the recurrence of urinary tract infections (UTIs). This study will also determine whether drinking cranberry juice for 6 months selects for less virulent bacteria in the rectal, vaginal, and urethral areas.

Description:

Participants in this study will be randomly assigned to consume either 8 ounces of cranberry juice or placebo juice twice a day for 6 months. Participants will have follow-up visits at 3 and 6 months, and whenever they experience a symptomatic episode. Urine, vaginal and rectal specimens will be taken at each visit to test for the presence of bacteria that cause urinary tract infections. Participants will complete a questionnaire at study entry, Day 3, Weeks 1 and 2, and monthly thereafter or whenever there is a recurrence of symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: December 2009
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Culture-confirmed urinary tract infection at study start

Exclusion Criteria:

• Other chronic disease

• Antibiotics within 48 hours prior to study start

• Hospitalization for any reason within 2 weeks prior to study start

• Stones in urinary tract

• Plans to leave Ann Arbor within 6 months after study start

• Allergy to cranberry or cranberry compounds

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Urinary Tract Infections

Intervention

Drug:
• Cranberry juice
TID dosage for UTI treatment

Dietary Supplement:
• Placebo cranberry juice
TID placebo dosage to match active comparator

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Culture		per visit	No